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Gottlieb details US FDA's FY'20 funding demands on his way out

Scott Gottlieb has laid out the U.S. Food and Drug Administration's funding demands to Congress for fiscal 2020 in greater detail, but with only weeks left as commissioner, he will not see whether any of the plans come to fruition.

The FDA commissioner surprised many in his agency and the industry when he revealed on March 5 that he planned to exit the FDA in early April after less than two years on the job.

Gottlieb's departure comes just as the Trump administration has started the process of haggling with Congress over fiscal 2020 funds. His temporary replacement, Ned Sharpless, currently the director of the U.S. National Cancer Institute, will guide the funding process for the FDA until a permanent commissioner is put in place — an action that may be several months away.

In a more detailed document posted online March 18, Gottlieb said the agency wants to spend the $6.1 billion the administration requested for the FDA to reduce the U.S. addiction crises — an epidemic regulators' actions helped to spur. The FDA also plans to leverage innovation and competition for drugs and other medical treatments; empower consumers and patients to make better and more informed choices about their diets and health; and strengthen the agency's science and risk-based decision-making processes.

Unlike the 12% cuts in spending the other agencies within the Department of Health and Human Services would have under the Trump administration's request, the FDA is seeking a 12% boost — an increase of $643.1 million over the fiscal 2019 annualized continuing resolution amount.

About $3.3 billion of fiscal 2020 funds would be under the budget authority from Congress, while $2.8 billion would come from the user fees the FDA collects from drugmakers and the other industries the agency regulates.

Of the funds the FDA is requesting, $3.8 billion — $1.8 billion in budget authority and $1.9 billion in user fees — would be directed to the agency's activities involving medical product safety and availability.

Priorities

The agency said its latest funding request aligns with the priorities outlined in its January 2018 Strategic Policy Roadmap.

The FDA wants to spend $55 million in fiscal 2020 on ongoing efforts to address the opioid crisis. Some of those funds would be devoted to additional lab needs for its international mail facilities initiative. The agency plans to increase its field and center operational capacity to review up to 100,000 packages annually.

Efforts to lower drug prices

The FDA is also planning to use $27 million to modernize its generic-drug review and approval processes and enable more consistent regulatory decision-making.

The FDA's spending proposal would expand current efforts to streamline and automate the review of the drug quality section of the generic application to include other disciplines engaged in the assessments, leading to faster approval of the products — a key plank in the Trump administration's blueprint to lower Americans' costs on prescription medicines.

In the overall March 11 budget document, HHS had already noted that the FDA was aiming to reform its 180-day exclusivity process for generic companies, in which the first to file an application seeking approval of a cheaper version of a brand-name medicine is granted six months of market exclusivity.

The FDA wants to tweak that process, including clarifying the rules under which a company must forfeit the 180-day exclusivity. Making those changes could increase generic competition and choice for consumers, according to the agency.

Regulators also are asking for new authority to summarily deny citizen petitions the FDA has determined are shams aimed at impeding generic competition.

Cures Act boost

The FDA also noted that the 21st Century Cures Act authorized $75 million for the agency. The legislation, which was signed by President Barack Obama in December 2016, had set up a $500 million innovation account for the agency to be used over nine years.

The funds will help the FDA implement provisions to accelerate medical product innovation, reduce regulatory burden, enhance efforts for critical scientific and methodological research, and increase the involvement of patients and their perspectives in research and the medical product development process, the agency said.

The Cures Act also provided the FDA with new authorities to improve its ability to compete with industry and academia in hiring and retaining scientific experts.

Antibiotics and countermeasures

The 2016 law also created a regulatory pathway to facilitate the development and approval of antibacterial and antifungal drugs to treat serious or life-threatening infections in limited populations of patients with unmet needs.

The FDA noted that it already published draft guidelines last year for the recommended criteria, processes and other general considerations for demonstrating safety and effectiveness of drugs approved under the so-called LPAD pathway. The agency is under a mandate to finalize the guidelines by February 2020.

The FDA also requested $7 million to support its review and regulatory science capacity to facilitate medical countermeasures readiness to respond to chemical, biological, radiological, nuclear and emerging infectious disease threats.

Manufacturing and real-world evidence

The FDA is also asking Congress for $38.5 million to advance modern drug and biological product manufacturing technologies that have the potential to accelerate new, more targeted therapies, enhance product quality, allow the vaccine supply to be more easily ramped up on short notice and bolster stability in the U.S. drug supply to meet domestic and global needs.

New manufacturing platforms would also contribute to the development of personalized medicines and may help reduce the cost and uncertainty of adopting new manufacturing technologies, the FDA said.

The agency also is requesting $60 million to advance the use of real-world evidence and to support premarket evaluations and post-market safety of products.